A single-centre, open-label, phase I study to evaluate the diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) Position Emission Tomography (PET) in Urothelial Cancer Patients

Phase 1

• Conditions: Metastatic urothelial carcinoma; Bladder cancer; Cancer - Bladder

• Registration Number: ACTRN12621000411842
• Lead Sponsor: South Metropolitan Health Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-15
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
2.Negative serum pregnancy test in female patients of childbearing potential at screening and consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
3. Histologically diagnosed with urothelial carcinoma or bladder cancer (or upper tract urothelial carcinoma diagnosed based on standard imaging and malignant urine cytology or direct visualisation on ureteroscopy) or known metastatic urothelial carcinoma or bladder cancer (based on previous imaging and /or histopathology)

Exclusion Criteria

1.Active malignancy other than urothelial carcinoma or bladder cancer
2.Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
3.Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
4.Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
5.Serious non-malignant disease that may interfere with the objectives of the study
6.Renal insufficiency with glomerular filtration rate less than or equal to 45 mL/min/1.73m2
7.Pregnancy or lactation
8.Exposure to murine or chimeric antibodies within the last 5 years
9.Known hypersensitivity or human anti-chimeric antibodies against girentuximab
10.Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
11.Contraindications to FDG PET/CT

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of using 89Zr-TLX250 PET/CT as a diagnostic and staging tool in urothelial carcinoma and bladder cancer will be defined by the ability to recruit to the target sample size within the study duration. This reflects a willingness of clinicians to refer patients for this study and a willingness of patients to undergo 89Zr-TLX250 PET/CT as for diagnosis or staging. <br><br>To assess this outcome, all study records such as electronic Case Report Form data, imaging results, histopathology results, diagnostic performance (sensitivity, specificity, positive and negative predictive values, accuracy), and safety evaluation (standard laboratory, physical examination, 12-lead electrocardiogram, vital signs, and adverse events) will be monitored and audited.<br><br>[Upon study completion of 18 months]